title: Detection of sentinel lymph node metastases in cervical cancer: assessment of KRT19 mRNA in the one-step nucleic acid amplification (OSNA) method.
abstract: OBJECTIVE
  The purpose of this study was to examine the utility of the one-step nucleic acid amplification (OSNA) assay using cytokeratin (CK) 19 (KRT19) messenger RNA (mRNA) for the detection of sentinel lymph node (SLN) metastases in cervical cancer patients.
  
  
  METHODS
  To determine a cutoff value, KRT19 mRNA was assessed by OSNA assay using 239 lymph nodes (LNs) (217 histopathologically negative LNs and 22 positive LNs). A cutoff value was determined by statistical analysis of the copy numbers obtained by OSNA assay. Subsequently, performance evaluation of the OSNA assay (applying the cutoff value above) on 130 SLNs (32 patients) was used to investigate (through concordance) whether the OSNA assay exhibited diagnostic performance equivalent to the two-mm interval histopathological examination.
  
  
  RESULTS
  Two hundred fifty copies/μL of KRT19 mRNA in the OSNA assay appeared to be an optimal cutoff value. In performance evaluation of the OSNA assay, we identified five positive SLNs and 125 negative SLNs by OSNA assay using KRT19 mRNA, exhibiting 96.2% agreement with two-mm interval histopathological examination.
  
  
  CONCLUSIONS
  Our results indicated that the KRT19 mRNA OSNA assay can detect LN metastases as accurately as two-mm interval histopathological examination and thus may be an effective additional or alternative method for a rapid intra-operative examination of SLNs in cervical cancer.
authors.affiliation: Department of Obstetrics and Gynecology, Tohoku University School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Okamoto
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Niikura
authors.forename: Kadzuki
authors.initials: K
authors.lastname: Nakabayashi
authors.forename: Kayo
authors.initials: K
authors.lastname: Hiyama
authors.forename: Maki
authors.initials: M
authors.lastname: Matoda
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Takeshima
authors.forename: Mika
authors.initials: M
authors.lastname: Watanabe
authors.forename: Satoru
authors.initials: S
authors.lastname: Nagase
authors.forename: Takeo
authors.initials: T
authors.lastname: Otsuki
authors.forename: Nobuo
authors.initials: N
authors.lastname: Yaegashi
mesh_terms: D000328:Adult; D014408:Biomarkers, Tumor / Q000235:genetics / Q000378:metabolism*; D005260:Female; D006801:Humans; D053539:Keratin-19 / Q000235:genetics*; D008198:Lymph Nodes / Q000378:metabolism* / Q000473:pathology; D008207:Lymphatic Metastasis; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques; D012333:RNA, Messenger / Q000378:metabolism*; D012372:ROC Curve; D002583:Uterine Cervical Neoplasms / Q000235:genetics / Q000378:metabolism / Q000473:pathology*; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor; D053539:Keratin-19; D012333:RNA, Messenger
keywords: Cervical cancer; Cytokeratin 19; Micrometastasis; One-step nucleic acid amplification (OSNA); Sentinel lymph node (SLN)